FDA Authorizes Pfizer’s Covid-19 Vaccine for Kids 5 to 11

The lower-dose vaccine could be administered as soon as this Wednesday, pending CDC approval

A female doctor wearing a mask vaccines a young girl wearing a mask
The recent decision expands vaccine eligibility to roughly 28 million American children. bogdankosanovic via Getty Images

The Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11. The move, which comes as a relief to public health officials and parents eager to protect kids from Covid-19, increases vaccine eligibility to roughly 28 million American children. If the Centers for Disease Control and Prevention (CDC) signs off on the emergency use authorization as anticipated, kids could start getting shots as early as this Wednesday, per Noah Weiland and Sharon LaFraniere of the New York Times.

"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against Covid-19 will bring us closer to returning to a sense of normalcy," said the FDA's acting commissioner Janet Woodcock in a statement Friday. She added that safety data had been carefully evaluated to determine that “this vaccine meets our high standards.”

Before authorizing the vaccine, the FDA reviewed Pfizer’s study on roughly 4,700 children ages 5 to 11. Pfizer’s vaccine formulation for kids contains just one-third of the active ingredient in the adult and teen shots—a dose that prompts a strong immune response while minimizing side effects, the company said. Like the adult vaccine, the lower-dose shots are administered in two doses three weeks apart. Pfizer's ongoing study found the vaccine was safe and nearly 91 percent effective in preventing symptomatic Covid-19 infections. 

While children are much less likely to become infected and seriously ill from Covid-19 compared to adults, serious pediatric cases have increased with the spread of the Delta variant. Since the beginning of the pandemic, around 8,300 children ages 5 to 11 have been hospitalized with Covid-19 and at least 170 kids in that age group have died, the New York Times reports. The pandemic has had a disproportionately large impact on kids of color, who are more likely to become infected with and die from Covid-19 than white children.

"Tragically, Covid-19 was among the top 10 leading causes of death for children 5 through 11 years of age in the U.S.," Woodcock added. "These are really starting statistics.”

Before shots can be distributed to pharmacies and pediatricians an advisory panel to the CDC will deliberate the details of the vaccine’s use in elementary-school-age kids. Depending on the outcome of the meeting, which is slated for Tuesday, CDC director Rochelle Walensky will make the final decision on the details of the vaccine’s use, according to CNN’s Maggie Fox. If everything goes as expected, kids could be eligible to receive their first shot this week.

Some states have already started ordering vaccines doses in preparation for the announcement. The White House says millions of doses of vaccines are ready to ship and will be available for children as soon as the CDC signs off. The Biden administration has assured parents that children’s shots will be easily accessible at familiar locations like pediatrician offices, community health centers, and local pharmacies.

“More than 6 million children have been infected with this virus since the beginning of the pandemic, and children have suffered in numerous other ways,” said Lee Savio Beers, president of the American Academy of Pediatrics, in a statement. “The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they've missed during the pandemic.”

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